NDC 24090-681

Primlev

Oxycodone And Acetaminophen

Primlev is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Akrimax Pharmaceuticals, Llc. The primary component is Oxycodone Hydrochloride; Acetaminophen.

Product ID24090-681_8488e9ac-74ea-6534-e053-2991aa0af9e9
NDC24090-681
Product TypeHuman Prescription Drug
Proprietary NamePrimlev
Generic NameOxycodone And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA040608
Labeler NameAkrimax Pharmaceuticals, LLC
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 24090-681-88

100 TABLET in 1 BOTTLE, PLASTIC (24090-681-88)
Marketing Start Date2011-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24090-681-79 [24090068179]

Primlev TABLET
Marketing CategoryANDA
Application NumberANDA040608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-02
Marketing End Date2016-02-27

NDC 24090-681-88 [24090068188]

Primlev TABLET
Marketing CategoryANDA
Application NumberANDA040608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-01
Marketing End Date2020-11-29

NDC 24090-681-71 [24090068171]

Primlev TABLET
Marketing CategoryANDA
Application NumberANDA040608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-02
Marketing End Date2016-02-27

NDC 24090-681-85 [24090068185]

Primlev TABLET
Marketing CategoryANDA
Application NumberANDA040608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-01
Marketing End Date2017-11-09

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:616098ee-42dd-4d10-badb-be628e7763fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1537120
  • 1014632
  • 1014599
  • 1537116
  • 1014615
  • 1537122
    • UPC Code
  • 0324090682886
  • 0324090681889
  • 0324090683883

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "Primlev" or generic name "Oxycodone And Acetaminophen"

    NDCBrand NameGeneric Name
    24090-682PrimlevPrimlev
    24090-681PrimlevPrimlev
    24090-683PrimlevPrimlev
    0054-0551Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2981Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2982Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2983Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0527-1669Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0527-1671Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0904-7093OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophen
    0904-7094OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophen
    0904-7095OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophen
    10544-621Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-184Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-185Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-186Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0054-3686RoxicetOxycodone and Acetaminophen
    0054-4650RoxicetOxycodone and Acetaminophen
    0054-8648RoxicetOxycodone and Acetaminophen
    0054-8650RoxicetOxycodone and Acetaminophen

    Trademark Results [Primlev]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRIMLEV
    PRIMLEV
    77720071 3804482 Live/Registered
    MIST PHARMACEUTICALS, LLC
    2009-04-22
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